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Background: Epirubicin, cisplatin, and5-FU (ECF) is one of the most commonly usedfirst-line chemotherapy regimens in metastaticgastric cancer. However, due to protractedinfusion schedule, need for special infusionpumps, and catheter-related complications, thepractical utility and acceptability of standardECF regimen are limited, particularly inresource-constrained settings including India.Materials and Methods: In the present study, wehave used a more convenient modification of thestandard ECF protocol (using 5 days intravenousinfusion of 5-FU at a dose of 750 mg/m2/day, givenover 6 h through a peripheral venous line), inIndian patients with metastatic gastric orgastroesophageal junction (GEJ) adenocarcinoma.The primary endpoint was overall survival (OS).The secondary endpoints were overall response rate(ORR), progression-free survival (PFS), andtoxicity profile. Results: Between January 2014and December 2017, 107 patients were assigned andtreated with this modified ECF regimen. The medianage was 52 years (range, 34–62); 66.3% were malesand 36.5% of the patients had ≥ 3 metastaticdisease site involvement at baseline. Dosereductions due to toxicity were required in 14.9%of the patients. The ORR was 32.7%; median PFS andOS were 5.9 months (95% confidence interval [CI]:4.7–6.9) and 10.4 months (95% CI: 8.4–11.8),respectively. Both the hematological andnonhematological toxicities were manageable, andthere was no toxicity-related death. The mostfrequent Grade 3–4 adverse events were neutropenia(18.7%), febrile neutropenia (13.1%), mucositis(5.6%), and diarrhea (5.6%). Conclusions: In thepresent study, the modified ECF regimendemonstrated significant efficacy with anacceptable toxicity profile in Indian patientswith metastatic gastric and GEJ adenocarcinoma.The survival outcomes of this modified schedulewere comparable with those of the standard ECFregimen, as reported earlier. Clearly, thismodified and more convenient ECF protocol shouldbe explored and validated through largeprospective randomized trials.

south asian journal of cancer

Modified Epirubicin, cisplatin, and 5-FU regimen as first-line chemotherapy in metastatic gastric or gastroesophageal junction adenocarcinoma: A Phase II study